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April 30, 2014 By: galadmin

FDA Reviews Psychiatric Side Effects of Chantrix

The U.S. Food and Drug Administration (FDA) announced Friday it will convene a public meeting in October to review the risks of psychiatric and behavioral side effects with Pfizer’s anti-smoking drug Chantrix.

The FDA said in a federal notice that it will convene its panel of psychiatric drug experts to discuss the pill’s risks and how to manage them.

Since 2009, Chantrix has carried the government’s strongest safety warning due to links to hostility, agitation, depression and suicidal thoughts. The warned was added after the FDA received dozens of reports of suicide and suicidal behavior among patients taking Chantrix.

At that time, the FDA also required Pfizer to conduct additional studies.

A spokeswoman for Pfizer said Friday that the company recently submitted new data to the FDA designed to show the drug’s safety.

In 2011, former running champion, Tim Danielson, 65 of San Diego, shot his ex-wife Ming Qi, 48, and then tried to gas himself to death by inhaling the fumes of a gas generator in the home they shared. His attorneys say he was suffering depression from Chantrix use at the time of the killing. Danielson began taking the anti-smoking drug Chantix weeks before Ming Qi’s death. The drug has possible side effects including hostility, agitation, depressed mood, suicidal thoughts or actions.

Danielson, a former high school champion distance runner who worked as an engineer and Qi, a Chinese national and university professor whom he met online, married in 2006 and divorced in 2008.

At the time of her death, Ming had moved into the former husband’s home for financial reasons. It was reported that the pair argued after Danielson discovered Qi was dating another man. Danielson shot her as she tried to run away and once she was on the ground, he put the rifle to her head and pulled the trigger. She was shot six times. Danielson then carried her body upstairs to his bedroom and turned on the generator to kill himself by carbon monoxide poisoning.

He sent an email to his sister-in-law telling her what he had done. She notified police and they discovered Ming’s dead body and Danielson, who was near death. He is expected to take the stand and tell jurors about how Chantix affected his mind.

Tim Danielson pleaded not guilty and is awaiting trial without bail since 2011.

As of July 1, 2009, the FDA requires Chantix to carry a black-box warning, the agency’s strongest safety warning, due to public reports of side effects including depression and suicidal thoughts and actions.

More than 2,700 lawsuits, now consolidated, have been filed against Pfizer, the manufacturer of Chantix, allegeging that the drug caused suicidal thoughts, aggressive and erratic behavior, depression and loss of memory in patients.

In recent months, Pfizer has settled two high profile test cases, but has maintained that the drug safe to use.

Jury selection in Danielson’s trial begins Wednesday.

If you or a loved one suffered adverse reactions from Chantix use, contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878).

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